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Low Intensity Focused Ultrasound Treatment for Drug-Resistant Epilepsy: An Efficacy Trial (LIFUS)

Primary Purpose

Drug Resistant Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focused ultrasound
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Drug Resistant Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects at least eighteen (18) years of age
  • Subjects with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness (ie failed at least two trials of antiepileptic drugs for seizures), as determined by one of the BWH epilepsy neurologists based on clinical seizure semiology and/or EEG findings.
  • Subjects who experience at least 1-2 seizures per month on average, are aware of or have reliable caregivers who are aware of when seizures occur and can reliably log seizure frequency
  • Subjects who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments.

Exclusion Criteria:

  • Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing
  • Subjects with dementia or other progressive degenerative disease, delirium or active psychosis
  • Subjects with ferromagnetic materials in the head
  • Subjects with severe cardiac disease, increased intracranial pressure, or a Transcutaneous Electrical Nerve Stimulation (TENS) unit
  • Subjects who have primary generalized epilepsy or non-epileptic seizures
  • Subjects who have experienced status epilepticus in the 3 months leading up to enrollment in the study
  • Subjects (females) who are pregnant, or are of childbearing potential and not willing to use reliable birth control during the treatment period.
  • Subjects who are unable to get a brain MRI for any reason (implanted metal in body, inability to lie still)
  • Subjects with current brain tumors or an intracranial vascular lesion
  • Subjects with severe, uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation.
  • Subjects with holes in the treatment area of the skull from trauma or prior surgery
  • Subjects with pacemakers, medication pumps, and other implanted electronic hardware. If a subject has a working Vagal Nerve Stimulator in place, the device will be turned off prior to each treatment session and then turned back on after each session.

Sites / Locations

  • Brigham and women's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug-Resistant Epilepsy (temporal lobe)

Arm Description

Pulsed low intensity focused ultrasound

Outcomes

Primary Outcome Measures

Patient tolerability of moderate term, repeated exposure toPulsed Low-Intensity Focused Ultrasound (PLIFUS) (Adverse Events assessment)
The aim of the proposed pilot study is to investigate patient tolerability of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy. We hypothesize that the treatments will be well-tolerated, without adverse events.
Efficacy of PLIFUS in reducing seizure frequency
The aim of the proposed pilot study is to investigate patient efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy .We hypothesize that PLIFUS stimulation will result in mechanical disruption of the target tissue (here, the epileptogenic focus), preserving the integrity of the tissue but rendering it unable (or less able) to mount seizure activity for a period of time. We, therefore, will assess improvement in subjects' seizure frequency by evaluating seizure frequency during and 30 days after the treatment period relative to a 30 day pre-treatment baseline period.
Effect of PLIFUS on patient EEG (evaluate number of attenuated epileptiform discharges)
We hypothesize that subjects' EEGs will show improvement (fewer and/or attenuated epileptiform discharges). Study Epileptologists (either the PI or Co-I) will interpret EEG results during the first and last treatment session.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2019
Last Updated
January 26, 2021
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03868293
Brief Title
Low Intensity Focused Ultrasound Treatment for Drug-Resistant Epilepsy: An Efficacy Trial
Acronym
LIFUS
Official Title
Low Intensity Focused Ultrasound Treatment for Drug-Resistant Epilepsy: An Efficacy Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
February 7, 2022 (Anticipated)
Study Completion Date
February 7, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the proposed pilot study is to investigate patient tolerability and efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy.
Detailed Description
The aim of the proposed pilot study is to investigate patient tolerability and efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy. We hypothesize that the treatments will be well-tolerated, subjects' EEGs will show improvement (fewer epileptiform discharges), and that subjects will experience a reduction in seizure frequency as a result of the treatment without adverse events. Due to the lack of options for patients with drug-resistant epilepsy, investigations into alternative noninvasive treatments are warranted. PLIFUS has been shown to safely modulate neuronal tissue, and is non-invasive and painless. Several human studies have shown that the use of PLIFUS can suppress somatosensory evoked potentials and induce functional magnetic resonance imaging (MRI) responses. Once the subject is enrolled in the study, the subject will be scheduled for a standard brain MRI scan at BWH if they have not had one in the last 3 months. The subject will be asked to keep track of their seizure events in the Daily Seizure Log Diary from the screening visit until 2 months after the last treatment session. The treatment period will include 8 treatment sessions total. These will occur 2 days per week for 4 weeks, each lasting approximately 1-2 hours, starting 1 month after seizure logging begins.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Resistant Epilepsy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug-Resistant Epilepsy (temporal lobe)
Arm Type
Experimental
Arm Description
Pulsed low intensity focused ultrasound
Intervention Type
Device
Intervention Name(s)
Focused ultrasound
Intervention Description
Pulsed low intensity focused ultrasound
Primary Outcome Measure Information:
Title
Patient tolerability of moderate term, repeated exposure toPulsed Low-Intensity Focused Ultrasound (PLIFUS) (Adverse Events assessment)
Description
The aim of the proposed pilot study is to investigate patient tolerability of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy. We hypothesize that the treatments will be well-tolerated, without adverse events.
Time Frame
3 months
Title
Efficacy of PLIFUS in reducing seizure frequency
Description
The aim of the proposed pilot study is to investigate patient efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy .We hypothesize that PLIFUS stimulation will result in mechanical disruption of the target tissue (here, the epileptogenic focus), preserving the integrity of the tissue but rendering it unable (or less able) to mount seizure activity for a period of time. We, therefore, will assess improvement in subjects' seizure frequency by evaluating seizure frequency during and 30 days after the treatment period relative to a 30 day pre-treatment baseline period.
Time Frame
3 months
Title
Effect of PLIFUS on patient EEG (evaluate number of attenuated epileptiform discharges)
Description
We hypothesize that subjects' EEGs will show improvement (fewer and/or attenuated epileptiform discharges). Study Epileptologists (either the PI or Co-I) will interpret EEG results during the first and last treatment session.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects at least eighteen (18) years of age Subjects with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness (ie failed at least two trials of antiepileptic drugs for seizures), as determined by one of the BWH epilepsy neurologists based on clinical seizure semiology and/or EEG findings. Subjects who experience at least 1-2 seizures per month on average, are aware of or have reliable caregivers who are aware of when seizures occur and can reliably log seizure frequency Subjects who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments. Exclusion Criteria: Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing Subjects with dementia or other progressive degenerative disease, delirium or active psychosis Subjects with ferromagnetic materials in the head Subjects with severe cardiac disease, increased intracranial pressure, or a Transcutaneous Electrical Nerve Stimulation (TENS) unit Subjects who have primary generalized epilepsy or non-epileptic seizures Subjects who have experienced status epilepticus in the 3 months leading up to enrollment in the study Subjects (females) who are pregnant, or are of childbearing potential and not willing to use reliable birth control during the treatment period. Subjects who are unable to get a brain MRI for any reason (implanted metal in body, inability to lie still) Subjects with current brain tumors or an intracranial vascular lesion Subjects with severe, uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation. Subjects with holes in the treatment area of the skull from trauma or prior surgery Subjects with pacemakers, medication pumps, and other implanted electronic hardware. If a subject has a working Vagal Nerve Stimulator in place, the device will be turned off prior to each treatment session and then turned back on after each session.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen J Bubrick, MD
Phone
617-732-7432
Email
ebubrick@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick S Trouten, BA
Phone
857-307-2383
Email
ptrouten@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen J Bubrick, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen J Bubrick, MD
Phone
617-732-7432
Email
ebubrick@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Patrick S Trouten, BA
Phone
857-307-2383
Email
ptrouten@bwh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Low Intensity Focused Ultrasound Treatment for Drug-Resistant Epilepsy: An Efficacy Trial

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